BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC

    MDR report key: 394198 · Received May 10, 2002

    Report

    Report Number
    2939301-2002-06181
    Event Type
    Malfunction
    Date Received
    May 10, 2002
    Report Date
    May 7, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPRTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH BASIC METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 137, 170, 102, 101 AND 128 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES. PATIENT USING EXPIRED SOLUTION. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR